Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
研究概览
简要总结
This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.
详细描述
Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent and comply with study assessment for the duration of one year
- •Age >= 25 years
- •Polypoidal Choroidal Vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- •BCVA using ETDRS 20/32 to 20/400
排除标准
- •Any history of previous vitrectomy
- •Previous cataract or ocular surgery within 2 months of day 0
- •Active intraocular inflammation in the study eye
- •Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Participation with another investigational drug within the past 30 days
- •Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry
- •Blood pressure >180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable)
- •Pregnancy
研究组 & 干预措施
Single Arm study
Single arm study:
Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
干预措施: ranibizumab intravitreal injection (Drug)
结局指标
主要结局
Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
时间窗: 1 year
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
时间窗: 1 Year
次要结局
- Efficacy as measured by the mean change from baseline in VA at 6 and 12 months(1 Year)
- Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12(1 Year)
- Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams(1 Year)
- Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography(1 Year)
- Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12.(1 Year)
研究者
Gregg T. Kokame, MD
Medical Director, The Retina Center at Pali Momi
Hawaii Pacific Health